ABSTRACT Maximizing access and minimizing costs of delivery are key challenges for optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV-1 prevention. In Africa, PrEP will be added to an already-burdened health infrastructure and the ability of the health systems to maximize PrEP access will necessitate finding novel delivery strategies. Since 2017, in collaboration with the Kenyan Ministry of Health, we have been conducting a large step-wedge randomized roll-out of PrEP delivery in 24 high-volume, PEPFAR-supported, public HIV care facilities in Kenya and use implementation science methods (including the RE-AIM framework) to document the process of PrEP delivery at scale in a national public health model (The Partners Scale Up Project). Preliminary assessments we done show high enthusiasm and uptake, continuation, and adherence for PrEP delivered in HIV clinics but also highlighted major barriers including lengthy visits with multiple stops (i.e., separate rooms for triage, HIV testing, counseling, clinical review, dispensing, and prescription) that burden the health system. We hypothesize that a nurse-led one-stop delivery model of PrEP could streamline patient flow and improve delivery efficiency in busy HIV care clinics, freeing providers to concentrate on urgent services, reducing client waiting time, minimizing stigma, and improving retention. In the context of our ongoing project, we have assembled a multidisciplinary team, to expand this work to identify more efficient and cost-effective strategies to deliver PrEP at scale by evacuating the feasibility of a highly novel care pathway: nurse-led one-stop PrEP delivery model. We will conduct this pilot research to develop a nurse-led one-stop PrEP delivery model at 4 PEPFAR supported HIV care clinics in in Kenya. In this pilot study, will enroll up to 300 PrEP users during two serial, four-month periods (150 per period): 1) an observational period with standard patient flow to serve as a contemporaneous control and 2) an observation study period with one-stop-PrEP provision. In the one-stop phase (intervention), all PrEP services (i.e., HIV testing, risk assessment, PrEP prescription, dispensing, and follow-up) will be done in a VCT room by a nurse-counselor. We will conduct novel process flow mapping and time and motion studies during the two periods to identify points of inefficiency and bottlenecks to optimal client flow. Key outcomes will be patient visit time, early PrEP continuation and adherence (quantified by tenofovir levels in dried blood spots). We will use interrupted time series analysis and causal inference methods to compare outcomes in the one-stop vs standard practice periods. We will also measure participants? and providers experiences with nurse-led one stop PrEP delivery using qualitative interviews and patient satisfaction using quantitative exit surveys. We have already demonstrated in our project that PrEP can be delivered in PEPFAR clinics, by PEPFAR staff; this supplement would extend further, aiming for greater efficiency, reduced workload, diminished client burden, and better outcomes.